Cox PharmaConsulting has considerable experience of managing pharmacovigilance projects. Typical client projects include updating Pharmacovigilance processes & systems and implementing a new organisational design. The consultancy can either Project Manage a clients project or offer facilitation and can ensure appropriate change managment.
For database and IT system based projects, Cox PharmaConsulting can offer:
Project Management of Safety Database System Validation & Implementation activities
Pharmacovigilance Business lead/expertise; Act as Pharmacovigilance representative in database system validation & implementations; e.g. Generation of the User Requirement Specification (URS)
The Consultancy's experience includes implementation of a complete global Pharmacovigilance System; including organisational design, recruitment, intra/interdepartmental communications, databases, support systems and processes.